Serotoninergic Pathways in Sudden and Unexpted Death in Epilepsy (SUDEP) (NCT02788318) | Clinical Trial Compass
TerminatedNot Applicable
Serotoninergic Pathways in Sudden and Unexpted Death in Epilepsy (SUDEP)
Stopped: difficulty recruiting patients
France2 participantsStarted 2014-01
Plain-language summary
The mortality rate is increased in patients with epilepsy, and especially among patients with drug-resistant epilepsy. This increased mortality is mainly related to the risk of SUDEP whose incidence is between 3.5 and 9 per 1,000 for patients with drug-resistant epilepsy. The term SUDEP refers to a sudden death occurring in a patient with epilepsy in whom anamnestic and post-mortem evidence does not identify a particular cause. Experimental and clinical data strongly suggest that most of SUDEP result from a postictal respiratory dysfunction progressing to terminal apnea. Due to the major role of serotonin in regulating breathing rhythms and data in animal models of epilepsy, it is envisaged that an alteration of serotonergic systems of the brainstem and limbic regions may play a central role in the occurrence of SUDEP. The objective of this work is to look for abnormalities of the serotonergic transmission within regulatory regions of respiratory and autonomic functions in brain samples prospectively collected in patients died from SUDEP.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age \>18 years
* Postmortem time before autopsy \<30 hours
Exclusion Criteria:
* Age \<18 years
* postmortem time before autopsy \> 30 hours
* Any subject whose brain would be of forensic interest
* Any patient who expressed an opposition to organ donation.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial was terminated before completing — does that mean the findings about serotonin pathways and SUDEP risk are incomplete or unreliable, and how does that affect what my doctor can tell me about my own risk?
2Since this study was looking at the density of serotonin-producing neurons in brain tissue after death, is there any way the research done so far has translated into anything clinically useful for monitoring or reducing SUDEP risk in living patients like me?
3Given that this research focused on a biological pathway involving serotonin, should I be asking whether any of my current epilepsy medications or antidepressants affect serotonin in a way that might be relevant to SUDEP?
4Are there any currently active studies on SUDEP prevention or serotonin-related epilepsy risks that my doctor thinks might be worth looking into, since this particular trial was terminated?
5How does my doctor currently assess my personal risk for SUDEP, and has any emerging research on serotonin pathways — including from studies like this one — changed how they think about that risk?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.